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IRCT20260818070718N1 IRCT 2026-09-09 Mazandaran University of Medical Sciences Effect of algae-containing spray on oral thrush Evaluation of the efficacy of C-phycocyanin oral spray compared to placebo on healing of recurrent aphthous stomatitis 2026-09-23 anticipated 30 Pending https://irct.ir/trial/92676 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed at the individual level using permuted-block randomization with a fixed block size of two. The allocation sequence will be generated using Random Allocation Software 2, with a 1:1 allocation ratio between the intervention and control groups. Given the initial sample size of 30 participants, the sequence will consist of 15 blocks of two, with one participant assigned to the intervention group and one to the control group within each block. Stratified randomization will not be used in this study. The random allocation sequence will be generated by an independent individual who is not involved in participant enrollment, implementation of the intervention, or outcome assessment. To ensure allocation concealment, the intervention product and placebo will be prepared in identical containers labeled with sequential, non-identifying codes. Each participant will receive the container bearing the corresponding number according to their order of enrollment, Blinding description: This study will be conducted in a double-blind manner. The participants, principal investigator, healthcare personnel involved in conducting the study, data collector, and outcome assessors will remain unaware of the assigned study product. The C-phycocyanin-containing spray and the placebo will be prepared in identical containers with equal volumes and labeled with sequential, non-identifying codes. The placebo will be made as similar as possible to the intervention product in terms of appearance, color, odor, and taste so that participants cannot identify their assigned group. The code key linking the study codes to the intervention and control groups will be held by an independent individual who has no role in participant enrollment, administration of the intervention, data collection, or outcome assessment. The dental student responsible for measuring the lesion diameter and the surrounding erythematous area and recording data on days 0, 3, 5, and 7 will also have no access to the allocation list. 2 Recurrent aphthous stomatitis. Intervention 1: Intervention group: An oral spray containing 8% C-phycocyanin will be applied to the lesion as two sprays, delivering approximately 20 mg of the active ingredient, three times daily for seven days. This spray will be developed at the Faculty of Pharmacy, Mazandaran University of Medical Sciences. Intervention 2: Control group: A placebo spray with a similar appearance and vehicle formulation but without C-phycocyanin will be administered at the same dose, frequency, and duration. This spray will be developed at the Faculty of Pharmacy, Mazandaran University of Medical Sciences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Alireza Ghanbari
Moallem Ave,
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3354 3861 Alireza11.ghanbari2001@gmail.com Mazandaran University of Medical Sciences scientific Dr. Anahita Ghorbani
Deputy for Research and Technology Building, Moalem Square, Sari, Mazandaran province
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4030 anahita1802@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age of 16 to 45 Recurrent aphthous stomatitis confirmed by examination and diagnosis by an oral and maxillofacial specialist A maximum of 24 hours have passed since the aphthous lesion developed The individual must be able to understand and follow treatment instructions 16 years 45 years Both Use of immunosuppressive drugs within the past month Systemic diseases affecting the development or progression of aphthous lesions Recurrent herpetiform aphthous lesions Poor oral hygiene Pregnancy Antibiotic use at the time of study entry Concurrent use of other treatments for aphthous lesions Known hypersensitivity to C-phycocyanin or product components and placebo K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Intervention group: An oral spray containing 8% C-phycocyanin will be applied to the lesion as two sprays, delivering approximately 20 mg of the active ingredient, three times daily for seven days. This spray will be developed at the Faculty of Pharmacy, Mazandaran University of Medical Sciences. Control group: A placebo spray with a similar appearance and vehicle formulation but without C-phycocyanin will be administered at the same dose, frequency, and duration. This spray will be developed at the Faculty of Pharmacy, Mazandaran University of Medical Sciences. Change in the diameter of the inflammatory halo surrounding the aphthous lesion, measured in millimeters. Timepoint: At baseline, before the intervention, and on days 3, 5, and 7 after starting treatment. Method of measurement: A metal caliper graduated in millimeters. Mazandaran University of Medical Sciences Approved 2026-07-01 Ethics committee of Mazandaran University of Medical Sciences Moallem Avenue Sari Mazandaran Iran (Islamic Republic of)